“I am Lee Abberley, Scientific Director in Bioanalysis at GSK (PA, USA). Our organization is Bioanalysis, Immunogenicity and Biomarkers (BIB) and we are responsible for the preclinical and clinical analytical support for ‘BIB’ endpoints across all GSKs therapeutic areas. We have a combination approach to study support whereby a proportion of work is internally supported and the remainder placed at external service providers. I am specifically responsible for the oversight and setting the strategy for bioanalytical work placed out at third parties.”
In what areas is the outsourced work you send?
Within the BIB area, we outsource primarily GLP and clinical studies for small molecule and clinical studies for large molecule projects. Specific types of work are supported internally, however, if projects are especially challenging from an analytical or timing perspective, or the required instrumentation is not available at a third party, these would certainly be supported internally. Maintaining internal capability also gives the opportunity to help troubleshoot externally placed work in a collaborative way.
What does your organization believe is important when outsourcing?
When selecting an external provider to support bioanalytical work, the highest priority consideration is given to capability and capacity. Quality, location and price are also very important, and typically we weigh up a combination of factors when deciding on placement of work. Location may be a key driver e.g. sample analysis in China, or specific instrumentation or expertise may be necessary, e.g. high-resolution mass spectrometry.
What are the challenges you face when sending outsourced work?
When placing work at an external provider timing is probably the most challenging aspect – making sure we can provide everything that needs to be in place to support a study, as well as the CRO being committed to the timelines and meeting the required deadlines. Communication can also be challenging especially when working across many time zones – proactivity and frequency of updates is the key to successful supplier relationship management.
Do you think the amount of outsourcing will change in the future?
The volume of outsourcing is unlikely to change substantially, but more likely the type and complexity of bioanalytical work will increase. As external providers invest in novel platforms and pharmaceutical companies look to externalize more complex pieces of work with different endpoints (e.g. PK and biomarkers for a single study), the time and resource necessary will rise. With more sophisticated automation in areas like liquid handling, it may be possible in the future to increase output further, which if coupled to reduced cost per sample, would make an attractive proposition for increased volume of externally supported work.
What factors do you think will increase outsourcing?
It is possible that because of growth in the CRO space, with mergers and acquisitions etc., we will see greater placement of pharma work at a single supplier. Instead of shopping around and having distinct parts of a study with different providers, the placement of work at a single supplier will likely increase as companies seek to leverage the benefits, such as cost and ease of contracting, of multi-service CROs.
Do you think the relationship between pharma and outsourcing companies will change in the future?
It is probable that there will be more diversity in the types of support that is available or requested – more ‘partnership’ and ‘in-sourcing’ approaches as well as consolidation of a more diverse range of services at a single provider.